NEOBREADS: Neoadjuvant Breast Diet Study

NCT03822715 | Terminated Phase 1

• 1 other identifier: IIT2018-25-MITA-NEOBREADS
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.

Conditions

Breast Cancer

Keywords

aromatase inhibitor; carbohydrate restricted diet; neo-adjuvant treatment; low-carb diet; low carb diet

Outcome Measures

Primary Outcomes (1)

• Diet adherence

  Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if \<20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient \<20% of calories were obtained from carbohydrates).

  6 months

Secondary Outcomes (9)

• Change in tumor size

  6 months

• Mean change in Ki67

  6 months

• Mean change in weight

  6 months

• Mean change in HbA1c

  6 months

• Mean change in insulin

  6 months

Study Arms (1)

Dietary intervention

EXPERIMENTAL

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors

Other: Carbohydrate restricted dietary intervention; Drug: standard of care aromatase inhibitors

Interventions

Carbohydrate restricted dietary intervention OTHER

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day)

Dietary intervention

standard of care aromatase inhibitors DRUG

standard of care aromatase inhibitors

Dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed breast cancer; clinical T2-T4c, any N, M0 invasive breast cancer by AJCC 7th edition clinical staging, with goal being surgery to complete excision of tumor in the breast and lymph node. Primary tumor must be palpable, largest diameter \>2.0 cm by physical examination or by radiological assessment.
• ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells
• HER2 Negative; HER2 negative is defined by the following criteria:
• or 1+ by IHC and ISH not done
• or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) \< 2
• + by IHC and ISH ratio (HER2 gene copy/chromosome 17) \< 2
• Ability to read, write, and understand English
• BMI \>24 kg/m2
• ECOG performance status 0-2
• Planning to receive neoadjuvant aromatase inhibitor therapy
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
• Age \> 18 years

You may not qualify if:

• Already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet
• Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
• Candidate for chemotherapy or HER2 directed therapy
• Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy, or investigational agent prior to study entry (initiation of AI within 30 days of diet initiation acceptable)
• Loss of \>10% of body weight within the previous 6 months
• Clinical or radiographic evidence of metastatic disease.
• Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program

Sponsors & Collaborators

• Monica Mita: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monica Mita, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Medicine

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 30, 2019
• Study Start: March 21, 2019
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

US (1)